{"id":453386,"date":"2024-10-20T09:29:59","date_gmt":"2024-10-20T09:29:59","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-13004-2022\/"},"modified":"2024-10-26T17:37:32","modified_gmt":"2024-10-26T17:37:32","slug":"aami-13004-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-13004-2022\/","title":{"rendered":"AAMI 13004 2022"},"content":{"rendered":"

This document describes a method for substantiating a select sterilization dose that achieves a sterility assurance level of 10-6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 13004:2022; Sterilization of health care products\u2014Radiation\u2014Substantiation of selected sterilization dose: Method VDmaxSD <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
5<\/td>\nCopyright information <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 13004:2022 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families <\/td>\n<\/tr>\n
21<\/td>\n4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family
4.3.2 Master product <\/td>\n<\/tr>\n
22<\/td>\n4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review
4.4.2 Modification to either product or manufacturing process, or both
4.4.3 Records
4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit <\/td>\n<\/tr>\n
23<\/td>\n5 Selection and testing of product for substantiating and auditing a selected sterilization dose
5.1 Nature of product
Table 1 \u2014 Nature of product items for sterilization dose substantiation and for sterilization dose auditing
5.2 Sample item portion (SIP) <\/td>\n<\/tr>\n
24<\/td>\nTable 2 \u2014 Examples for calculation of SIP <\/td>\n<\/tr>\n
25<\/td>\n5.3 Manner of sampling
5.4 Microbiological testing
5.5 Irradiation <\/td>\n<\/tr>\n
26<\/td>\n6 Method VDmaxSD\u2014Substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy
6.1 Rationale <\/td>\n<\/tr>\n
27<\/td>\n6.2 Procedure for Method VDmaxSD for multiple production batches
6.2.1 General
6.2.2 Stage 1: Obtain samples of product
6.2.3 Stage 2: Determine average bioburden
6.2.4 Stage 3: Obtain the selected sterilization dose <\/td>\n<\/tr>\n
28<\/td>\nTable 3 \u2014 Upper limit of average bioburden for selection of a given sterilization dose
6.2.5 Stage 4: Obtain VDmaxSD
Table 4 \u2014 Table in Clause 8 corresponding to the selected sterilization dose <\/td>\n<\/tr>\n
29<\/td>\n6.2.6 Stage 5: Perform verification dose experiment
6.2.7 Stage 6: Interpretation of results <\/td>\n<\/tr>\n
30<\/td>\n6.2.8 Confirmatory verification dose experiment
6.2.8.1 General
6.2.8.2 Stage 1: Obtain samples of product
6.2.8.3 Stage 2: Perform confirmatory verification dose experiment <\/td>\n<\/tr>\n
31<\/td>\n6.2.8.4 Stage 3: Interpretation of results
6.3 Procedure for Method VDmaxSD for a single production batch
6.3.1 Rationale
6.3.2 General <\/td>\n<\/tr>\n
32<\/td>\n6.3.3 Stage 1: Obtain samples of product
6.3.4 Stage 2: Determine average bioburden
6.3.5 Stage 3: Obtain the selected sterilization dose <\/td>\n<\/tr>\n
33<\/td>\n6.3.6 Stage 4: Obtain VDmaxSD
6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results <\/td>\n<\/tr>\n
34<\/td>\n6.3.9 Confirmatory verification dose experiment
6.3.9.1 General
6.3.9.2 Stage 1: Obtain samples of product
6.3.9.3 Stage 2: Perform confirmatory verification dose experiment <\/td>\n<\/tr>\n
35<\/td>\n6.3.9.4 Stage 3: Interpretation of results
7 Maintaining process effectiveness
7.1 General
7.2 Frequency of determination of bioburden
7.3 Sterilization dose audit
7.3.1 Frequency
7.3.2 Outcome <\/td>\n<\/tr>\n
36<\/td>\n7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD
7.3.3.1 General
7.3.3.2 Stage 1: Obtain samples of product
7.3.3.3 Stage 2: Determine average bioburden
7.3.3.4 Stage 3: Perform verification dose experiment <\/td>\n<\/tr>\n
37<\/td>\n7.3.3.5 Stage 4: Interpretation of results <\/td>\n<\/tr>\n
38<\/td>\n7.3.3.6 Confirmatory sterilization dose audit
7.3.3.6.1 General
7.3.3.6.2 Stage 1: Obtain samples of product
7.3.3.6.3 Stage 2: Perform confirmatory verification dose experiment
7.3.3.6.4 Stage 3: Interpretation of results <\/td>\n<\/tr>\n
39<\/td>\n7.3.3.7 Augmentation of a sterilization dose substantiated using Method VDmaxSD
7.3.4 Failure of a sterilization dose audit <\/td>\n<\/tr>\n
40<\/td>\n8 Tables of values for SIP
Table 5 \u2014 17,5 kGy selected sterilization dose for which the upper limit of average bioburden is 9,0 <\/td>\n<\/tr>\n
41<\/td>\nTable 6 \u2014 20 kGy selected sterilization dose for which the upper limit of average bioburden is 45 <\/td>\n<\/tr>\n
43<\/td>\nTable 7 \u2014 22,5 kGy selected sterilization dose for which the upper limit of average bioburden is 220 <\/td>\n<\/tr>\n
46<\/td>\nTable 8 \u2014 27,5 kGy selected sterilization dose for which the upper limit of average bioburden is 5 000 <\/td>\n<\/tr>\n
51<\/td>\nTable 9 \u2014 30 kGy selected sterilization dose for which the upper limit of average bioburden is 23 000 <\/td>\n<\/tr>\n
57<\/td>\nTable 10 \u2014 32,5 kGy selected sterilization dose for which the upper limit of average bioburden is 100 000 <\/td>\n<\/tr>\n
63<\/td>\nTable 11 \u2014 35 kGy selected sterilization dose for which the upper limit of average bioburden is 440 000 <\/td>\n<\/tr>\n
71<\/td>\n9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0)
Table 12 \u2014 Method VDmax17,5 substantiation (SIP less than 1,0) <\/td>\n<\/tr>\n
72<\/td>\n9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0)
Table 13 \u2014 Method VDmax30 substantiation (SIP equal to 1,0) <\/td>\n<\/tr>\n
73<\/td>\n9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5
Table 14 \u2014 Sterilization dose audit following which augmentation of the sterilization dose was required (selected sterilization dose substantiated using Method VDmax22,5) <\/td>\n<\/tr>\n
75<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 13004:2022 Sterilization of health care products\u2014Radiation\u2014Substantiation of selected sterilization dose: Method VDmaxSD<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n75<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":453395,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-453386","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/453386","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/453395"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=453386"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=453386"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=453386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}